Confidence Beyond Compliance

PharmaLex provide a broad array of clinical data management services to support this critical phase in clinical research. We help our clients generate high-quality, accurate, and statistically sound data from clinical trials. Our advanced technologies are combined with innovative solutions to reduce complexities and accelerate the drug development to marketing.

Our experts have proven experience in the management of eCRF, ePRO, IWRS, testing & validation covering all therapeutic areas. The end-to-end solution we offer can be adapted to the needs of our clients in order to create true value.

Our services include:

Study design

  • Input in CRF design
  • Creation of annotated CRF
  • Data Management Plan (DMP)
  • Data Cleaning Plan (DCP) & Programming
  • Data Validation Plan (DVP)
  • E-Platform setup (incl. eCRF/ePRO/IWRS), testing & validation
  • Data exchange with external data sources and systems (in/out)
  • ECRF completion guidelines

Study conduct

  • E-Platform and database hosting
  • Handling reference ranges
  • Data integration
  • Data Cleaning Process
  • (Risk-based) Data Monitoring through vertical and longitudinal analysis
  • Data exports

Study close-out

  • Data reconciliation across multiple sources and systems
  • Database lock, transfer & archiving
  • Data Management Report